Adherence, Medication Clinical Trial
Official title:
A Randomised Controlled Trial Assessing the Efficacy of Targeted Intervention for Topical Steroid Phobia.
NCT number | NCT03658252 |
Other study ID # | 2018/00481 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | May 4, 2019 |
Verified date | February 2020 |
Source | National University Health System, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Topical steroids are an important component of treatment for many dermatological conditions,
however 'Corticosteroid phobia' is a significant factor contributing to non adherence to
prescribed therapy.
The primary aim of this study is to determine the effectiveness of targeted education, and
involvement in a moderated social forum in reducing steroid phobia as assessed by the
TOPICOP© score. Secondary objectives include determining if a decrease in TOPICOP© score
correlates to an increase in compliance, or an improvement in quality of life.
Status | Completed |
Enrollment | 270 |
Est. completion date | May 4, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: Participants aged 21 years and above. Currently prescribed and expected to be on topical steroids for the next 3 months. Willing to provide telephone number or email address, and to be recontacted. Able to read and understand english. Exclusion Criteria: Not on topical steroids. Unable to understand english. Unable or unwilling to be contacted for follow up surveys. |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Health System, Singapore |
Singapore,
Dréno B, Thiboutot D, Gollnick H, Finlay AY, Layton A, Leyden JJ, Leutenegger E, Perez M; Global Alliance to Improve Outcomes in Acne. Large-scale worldwide observational study of adherence with acne therapy. Int J Dermatol. 2010 Apr;49(4):448-56. doi: 10.1111/j.1365-4632.2010.04416.x. — View Citation
Moret L, Anthoine E, Aubert-Wastiaux H, Le Rhun A, Leux C, Mazereeuw-Hautier J, Stalder JF, Barbarot S. TOPICOP©: a new scale evaluating topical corticosteroid phobia among atopic dermatitis outpatients and their parents. PLoS One. 2013 Oct 16;8(10):e76493. doi: 10.1371/journal.pone.0076493. eCollection 2013. — View Citation
Pawin H, Beylot C, Chivot M, Faure M, Poli F, Revuz J, Dréno B. Creation of a tool to assess adherence to treatments for acne. Dermatology. 2009;218(1):26-32. doi: 10.1159/000165628. Epub 2008 Oct 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in TOPICOP© score at 3 months | Validated score assessing topical corticosteroid (TCS) phobia. It consists of 12 items assessing three domains of TCS phobia, knowledge and beliefs, fears and behaviour on a 4 point likert scale. The individual domain and global scores are calculated as a percentage of the total score. A higher score indicated greater steroid phobia. | 3 months | |
Secondary | Change in TOPICOP© score at 1 month | Validated score assessing topical corticosteroid (TCS) phobia. It consists of 12 items assessing three domains of TCS phobia, knowledge and beliefs, fears and behaviour on a 4 point likert scale. The individual domain and global scores are calculated as a percentage of the total score. A higher score indicated greater steroid phobia. | 1 month | |
Secondary | Change in ECOB (Elaboration d'un outil d'evaluation de l'observance des traitements médicamenteux) score at 1 month | Score comprising 4 questions to assess patients awareness of their medication and compliance. Questions administered in english. Designed initially to assess adherence to topical and oral therapies in acne, but is used in this study to assess adherence to topical steroids. Range of total score is from 0-4. A score of 4 classifies the patient as adherent, and <4 as non adherent. | 1 month | |
Secondary | Change in ECOB (Elaboration d'un outil d'evaluation de l'observance des traitements médicamenteux) score at 3 month | Score comprising 4 questions to assess patients awareness of their medication and compliance. Questions administered in english. Designed initially to assess adherence to topical and oral therapies in acne, but is used in this study to assess adherence to topical steroids. Range of total score is from 0-4. A score of 4 classifies the patient as adherent, and <4 as non adherent. | 3 month | |
Secondary | Change in Dermatology Life Quality Index score at 1 month | Dermatology specific quality of life instrument. A 10 point questionnaire, with a total score range from 0 to 30. A higher score indicated greater impact on quality of life. | 1 month | |
Secondary | Change in Dermatology Life Quality Index score at 3 month | Dermatology specific quality of life instrument. A 10 point questionnaire, with a total score range from 0 to 30. A higher score indicated greater impact on quality of life. | 3 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Recruiting |
NCT04316715 -
Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care
|
N/A | |
Active, not recruiting |
NCT04602468 -
Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)
|
Phase 4 | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Enrolling by invitation |
NCT04676204 -
Relationship Between Oral DMT Burden and Adherence in MS
|
||
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Completed |
NCT05168449 -
The Impact of Pharmacist-led Mobile Application on Adherence in Chronic Kidney Disease Patients
|
N/A | |
Active, not recruiting |
NCT04612088 -
Intervention for Multivitamin Adherence on Bariatric Patients
|
N/A | |
Completed |
NCT03958331 -
Behavioral Economics and Adherence in Teens (BEAT!)
|
N/A | |
Completed |
NCT05233644 -
Medication Adherence in Heart Failure After Hospitalisation
|
||
Completed |
NCT03837496 -
Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03683966 -
MigALastat Therapy Adherence Among FABRY Patients: A Prospective Multicentral Observational Study
|
||
Withdrawn |
NCT04754867 -
Pre-Test of For the Future Self and Smoking Cessation
|
N/A | |
Recruiting |
NCT05996094 -
Antiretroviral Adherence and Drug-level Monitoring
|
||
Not yet recruiting |
NCT06056037 -
Making ART Work Among Brazilian Youth
|
N/A | |
Completed |
NCT03651596 -
Leveraging mHealth Messaging to Promote Adherence in Teens With CKD
|
N/A | |
Completed |
NCT03842436 -
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
|
Phase 4 | |
Completed |
NCT03081559 -
Improving Engagement in HIV Care for High-risk Women
|
N/A | |
Recruiting |
NCT05515497 -
BMT4me: Post-HSCT Medication Adherence mHealth App
|
N/A | |
Active, not recruiting |
NCT04065347 -
Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)
|